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NOT YET RECRUITING
NCT07825844
NA

Tools for Return of Facial Function

Sponsor: The University of Texas Medical Branch, Galveston

View on ClinicalTrials.gov

Summary

This study will evaluate novel intraoral (inside-the-mouth) splints designed to gently stretch facial tissues that have become tight or scarred following facial trauma, including burn injuries and gunshot wounds. Scar contractures can limit mouth opening, facial movement, and facial expressions, affecting daily function and quality of life. Participants aged 7 years and older with facial contractures will be fitted with one or more silicone splints selected by a trained speech-language pathologist based on each participant's areas of restriction. The splints are available in different shapes and sizes and are designed to provide passive stretching to targeted areas of the face and mouth. Researchers will assess changes in facial mobility, mouth opening, facial symmetry, and range of facial expression using clinical measurements and facial movement analysis software. The study will also help identify appropriate treatment protocols for use of the splints. The researchers expect that use of the splints may improve facial movement and function, reduce the effects of scar contractures, and potentially decrease the need for future surgical procedures to improve facial mobility. Findings from this study may support a new treatment option for individuals with facial scarring due to burns or other traumatic injuries.

Official title: Translating Science Into Tools for Return of Facial Function

Key Details

Gender

All

Age Range

7 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-12

Completion Date

2028-08

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DEVICE

Intraoral Stretching Splints

A set of three silicone intraoral splints (ball, bar, and boomerang shapes) designed to provide passive stretching of scarred or contracted orofacial tissues. Splints are available in multiple sizes and may be used unilaterally or bilaterally to target specific areas of facial tightness and restricted movement.

Locations (1)

The University of Texas Medical Branch

Galveston, Texas, United States